Sample size determination in group-sequential clinical trials with two co-primary endpoints

Koko Asakura, Toshimitsu Hamasaki, Tomoyuki Sugimoto, Kenichi Hayashi, Scott R. Evans, Takashi Sozu

研究成果: Article査読

15 被引用数 (Scopus)

抄録

We discuss sample size determination in group-sequential designs with two endpoints as co-primary. We derive the power and sample size within two decision-making frameworks. One is to claim the test intervention's benefit relative to control when superiority is achieved for the two endpoints at the same interim timepoint of the trial. The other is when superiority is achieved for the two endpoints at any interim timepoint, not necessarily simultaneously. We evaluate the behaviors of sample size and power with varying design elements and provide a real example to illustrate the proposed sample size methods. In addition, we discuss sample size recalculation based on observed data and evaluate the impact on the power and Type I error rate.

本文言語English
ページ(範囲)2897-2913
ページ数17
ジャーナルStatistics in Medicine
33
17
DOI
出版ステータスPublished - 2014 7 30
外部発表はい

ASJC Scopus subject areas

  • 疫学
  • 統計学および確率

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